The invention of this application relates generally to medical devices and methods of use in vessels, ducts or lumens of living beings, and more particularly to expandable prostheses and methods of use for the treatment of aneurysmal arterial disease.
The use of an intraluminal endovascular prosthesis for the treatment of aneurysmal arterial disease, e.g., an abdominal aortic aneurysm, has been attempted experimentally as an alternative to conventional vascular surgery. That experimentation involved the insertion into a blood vessel of a tubular prosthetic graft via the open insertion through a short segment exposed portion of the blood vessel.
Prior art experimentations have been fraught with failures and difficulties owing to various factors. In particular, the factors which must be addressed for adequate placement of the prosthesis, particularly if it is to be placed by percutaneous introduction from a remote site, (e.g., percutaneous introduction into the femoral artery), followed by passage through portions of the vascular system to the situs of the aneurysm (a desirable mode of introduction vis-a-vis direct arterial cut-down) are as follows. The graft should exhibit the ability to pass through a percutaneous sheath of reasonable size for passage to the arterial aneurysm. The graft should be able to pass through the aneurysm thrombus without dislodging emboli. These first two factors necessitate that the prosthesis be very small, (i.e., have a very small "crossing diameter"). The prosthesis should also be very flexible to pass over a guide wire or similar apparatus the enable it to be threaded or passed through a redundant, kink and potentially stenotic arteries to reach the aneurysm, without exhibiting a high risk of damaging those vessels. Typically with aortic aneurysms there is very little vascular tissue available to anchor the prosthesis sufficiently proximally, and to anchor and seal the prosthesis to the arterial wall to prevent leakage and/or migration of the prosthesis. Thus, the prosthesis should be constructed so that it can be readily secured in place within the aneurysmal space in the vessel so that it is resistant to migration. In addition the prosthesis must be sealed sufficiently to the arterial wall on the proximal and distal sides of the aneurysm prevent the ingress of blood into the interface between the prosthesis and the arterial wall to prevent emboli from being dislodged and freed to flow into the distal vascular system. Lastly, the prosthesis should be constructed so that it provides a passageway or lumen of sufficient diameter for blood to flow freely therethrough, while preventing subsequent rupturing of the aneurysm.
Heretofore the prior art has not provided any prosthesis and/or method of use which adequately addresses the above factors.
The following United States Letters patents have disclosed devices for the treatment of aneurysmal arterial disease: U.S. Pat. No. 4,562,596 (Kornberg); U.S. Pat. No. 5,207,695 (Trout III); U.S. Pat. No. 5,211,658 (Clouse); U.S. Pat. No. 5,275,622 (Lazarus et al.); U.S. Pat. No. 5,282,824 (Gianturco); U.S. Pat. No. 5,316,023 (Palmaz et al.); U.S. Pat. No. 5,330,528 (Lazim); U.S. Pat. No. 5,360,443 (Mazza et al.); U.S. Pat. No. 5,370,691 (Samson); U.S. Pat. No. 5,387,235 (Chuter); and U.S. Pat. No. 5,405,379 (Lane).
Accordingly, the need exists for apparatus and methods for effectively treating aneurysmal arterial disease.
In my U.S. Pat. No. 5,122,154, whose disclosure is incorporated by reference herein, there is disclosed an intraluminal bypass graft for revascularization of occluded arteries. That bypass graft is arranged for placement in a blood vessel, duct, or lumen, to hold it open and comprises a sleeve having plural stents secured to it at spaced locations therealong. The sleeve is an elongated tubular member formed of a conventional graft material which is flexible and impervious to the ingrowth of tissue. Each stent is a generally ring-like member formed a plurality of interconnected movable links and is mounted about the periphery of either the inner or outer surface, of the sleeve at selected points along the sleeve to form respective spaced first sleeve sections. Each of the first sections extends for only a portion of the length of the graft, thereby leaving a plurality of second sleeve sections interposed between the first sleeve sections. The stents and the sleeve are arranged to be expanded, by any suitable means, e.g., a balloon catheter, from a compact state to an expanded state to increase the inner cross sectional area diameter of the sleeve. In the expanded state the stents are resistant to contraction back to the compact state. The graft is able to bend with respect to its longitudinal axis to enable it to be readily accommodated within a curved blood vessel, duct, or lumen.
I have determined that the bypass graft of my above mentioned patent (or even portions of it), can be used to form a portion of a prosthesis of this invention. That prosthesis has the ability: to traverse tortuous or stenosed paths to the situs of the aneurysm without risk of damage to the vessel being traversed or dislodging a emboli; to remain permanently anchored in place against migration, while sealing and trapping any blood clot in the aneurysmal space between it and the arterial wall to prevent the egress of emboli therefrom; to prevent rupture of the aneurysm; and to provide for adequate blood flow through it.
In my aforementioned patent application Ser. No. 08/562,728 there is disclosed and claimed an intraluminal prosthesis for aneurysmal arterial disease which overcomes many of the disadvantages of the prior art.